Utira-C (Oral)

Urelle® is a combination of five medicines: hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate. It is used to relieve discomfort, swelling, pain, frequent urge to urinate, and cramps or spasms of the urinary tract caused by an infection or a diagnostic procedure.

Hyoscyamine is an antispasmodic drug that relieves muscle cramps or spasms. Methenamine and methylene blue are antiseptic drugs that help clear a urinary tract infection. Phenyl salicylate is a pain reliever. Sodium phosphate makes the urine more acidic, which helps methenamine work better.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check how you or your child are doing at regular visits. This will help your doctor see if the medicine is working correctly and decide if you should keep taking it.

If your or your child's symptoms do not get better or if they worsen, call your doctor.

Stop using this medicine and contact your doctor immediately if you or your child experience blurred vision, dizziness, or a rapid pulse.

This medicine will cause your urine to be colored blue. This is normal and is not a cause for concern.

This medicine will not cure a serious urinary tract infection and will only help relieve symptoms as long as you continue to take it.

Do not take any other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a drug, the chances of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medication, the following should be considered:

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medicine or any other drugs. Additionally tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific issues that would limit the usefulness of Urelle® in children. Nevertheless, use is not advised in children 6 years of age and younger.

Geriatric

No details is available on the relationship of age to the effects of Urelle® in geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this drug during breastfeeding. Weigh the potential benefits against the potential risks prior to taking this drug while breastfeeding.

Interactions with Medications

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your physician may want to change the dose, or other precautions may be necessary. When you are using this medication, it is especially critical that your healthcare professional know if you are using any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not advised. Your doctor may decide not to treat you with this medicine or change some of the other medicines you take.

• Acetazolamide
• Amitriptyline
• Amoxapine
• Amphetamine
• Atomoxetine
• Benzphetamine
• Bepridil
• Bupropion
• Burosumab-twza
• Carbamazepine
• Carbidopa
• Carbinoxamine
• Cisapride
• Clomipramine
• Codeine
• Cyclobenzaprine
• Desipramine
• Desvenlafaxine
• Deutetrabenazine
• Dexmethylphenidate
• Dextroamphetamine
• Doxepin
• Doxylamine
• Dronedarone
• Duloxetine
• Entacapone
• Fenfluramine
• Fluoxetine
• Fluvoxamine
• Hydroxytryptophan
• Imipramine
• Isocarboxazid
• Levodopa
• Levoketoconazole
• Levomilnacipran
• Linezolid
• Lisdexamfetamine
• Mafenide
• Maprotiline
• Meperidine
• Mesoridazine
• Methamphetamine
• Methylphenidate
• Milnacipran
• Mirtazapine
• Nortriptyline
• Ozanimod
• Paroxetine
• Phenelzine
• Phentermine
• Pimozide
• Piperaquine
• Potassium Citrate
• Protriptyline
• Pseudoephedrine
• Rizatriptan
• Safinamide
• Saquinavir
• Selegiline
• Serdexmethylphenidate
• Sertraline
• Silver Sulfadiazine
• Solriamfetol
• Sparfloxacin
• Sulfabenzamide
• Sulfacetamide
• Sulfacytine
• Sulfadiazine
• Sulfamerazine
• Sulfamethazine
• Sulfamethoxazole
• Sulfanilamide
• Sulfapyridine
• Sulfasalazine
• Sulfathiazole
• Sulfisoxazole
• Sumatriptan
• Tapentadol
• Terfenadine
• Thioridazine
• Tramadol
• Tranylcypromine
• Trazodone
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Viloxazine
• Vortioxetine
• Ziprasidone
• Zolmitriptan
• Zonisamide

Using this drug with any of the following drugs is usually not recommended, but may be required in some cases. If both medications are prescribed together, your physician may change the dose or how frequently you use one or both of the drugs.

• Aceclofenac
• Acemetacin
• Adagrasib
• Albuterol
• Alfentanil
• Alfuzosin
• Almotriptan
• Alprazolam
• Amantadine
• Amifampridine
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amtolmetin Guacil
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Atropine
• Azithromycin
• Balsalazide
• Bedaquiline
• Benzhydrocodone
• Bismuth Subsalicylate
• Bromazepam
• Bromfenac
• Brompheniramine
• Bufexamac
• Buprenorphine
• Bupropion
• Buserelin
• Buspirone
• Butalbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Celecoxib
• Ceritinib
• Cetirizine
• Chloroquine
• Chlorpheniramine
• Chlorpromazine
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clofazimine
• Clomipramine
• Clonazepam
• Clonixin
• Clothiapine
• Clozapine
• Cocaine
• Codeine
• Crizotinib
• Dabrafenib
• Daridorexant
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexibuprofen
• Dexketoprofen
• Dexmedetomidine
• Dextromethorphan
• Dibenzepin
• Diclofenac
• Difenoxin
• Diflunisal
• Dihydrocodeine
• Diphenoxylate
• Dipyrone
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Droperidol
• Droxicam
• Efavirenz
• Eletriptan
• Encorafenib
• Entrectinib
• Epinephrine
• Erdafitinib
• Erythromycin
• Escitalopram
• Esketamine
• Etodolac
• Etofenamate
• Etoricoxib
• Etrasimod
• Felbinac
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Fexinidazole
• Fingolimod
• Flecainide
• Flibanserin
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Formoterol
• Foscarnet
• Fostemsavir
• Frovatriptan
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Indomethacin
• Inotuzumab Ozogamicin
• Iobenguane I 123
• Iobenguane I 131
• Iproniazid
• Ivabradine
• Ivosidenib
• Ketamine
• Ketoconazole
• Ketoprofen
• Lacosamide
• Lapatinib
• Lasmiditan
• Lefamulin
• Lemborexant
• Lenvatinib
• Leuprolide
• Levocetirizine
• Levofloxacin
• Levorphanol
• Lithium
• Lofepramine
• Lofexidine
• Lopinavir
• Lorcaserin
• Lornoxicam
• Loxapine
• Loxoprofen
• Lumefantrine
• Lumiracoxib
• Macimorelin
• Magnesium Oxybate
• Magnesium Salicylate
• Meclofenamate
• Mefenamic Acid
• Mefloquine
• Melitracen
• Meloxicam
• Mesalamine
• Metaxalone
• Methacholine
• Methadone
• Metoclopramide
• Metronidazole
• Midodrine
• Mifepristone
• Mirtazapine
• Mobocertinib
• Moclobemide
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nabumetone
• Nafarelin
• Nalbuphine
• Naproxen
• Naratriptan
• Nefazodone
• Nepafenac
• Nialamide
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Norepinephrine
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Olsalazine
• Ondansetron
• Opipramol
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxaprozin
• Oxycodone
• Oxymetazoline
• Oxymorphone
• Oxyphenbutazone
• Ozanimod
• Pacritinib
• Paliperidone
• Palonosetron
• Panobinostat
• Parecoxib
• Paroxetine
• Pasireotide
• Pazopanib
• Pentazocine
• Periciazine
• Phenobarbital
• Phenylbutazone
• Piketoprofen
• Pimavanserin
• Piroxicam
• Pitolisant
• Ponesimod
• Posaconazole
• Potassium Oxybate
• Pregabalin
• Primidone
• Procainamide
• Procarbazine
• Prochlorperazine
• Proglumetacin
• Promethazine
• Propafenone
• Propyphenazone
• Proquazone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Rasagiline
• Relugolix
• Remifentanil
• Remimazolam
• Revefenacin
• Ribociclib
• Rofecoxib
• Ropeginterferon Alfa-2b-njft
• Salicylamide
• Salicylic Acid
• Salsalate
• Scopolamine
• Secretin Human
• Selpercatinib
• Sertraline
• Sevoflurane
• Sibutramine
• Siponimod
• Sodium Oxybate
• Sodium Salicylate
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sufentanil
• Sulfasalazine
• Sulindac
• Sulpiride
• Sunitinib
• Tacrolimus
• Tapentadol
• Telavancin
• Telithromycin
• Tenoxicam
• Tetrabenazine
• Tianeptine
• Tiaprofenic Acid
• Tiotropium
• Tolfenamic Acid
• Tolmetin
• Topiramate
• Trazodone
• Triclabendazole
• Trimipramine
• Triptorelin
• Trolamine Salicylate
• Valbenazine
• Valdecoxib
• Vandetanib
• Vardenafil
• Vemurafenib
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Ziprasidone
• Zolpidem
• Zuclopenthixol
• Zuranolone

Using this drug with any of the following drugs may cause an increased chance of certain side effects, but using both drugs may be the best therapy for you. If both medications are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose
• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Calcium Acetate
• Calcium Carbonate
• Calcium Citrate
• Chlorpropamide
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Glimepiride
• Glipizide
• Glyburide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Metformin
• Nateglinide
• Repaglinide
• Tolazamide
• Tolbutamide

Interactions with Food/Tobacco/Alcohol

Certain medications should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain drugs may as well cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medication. Make sure you inform your doctor if you have any other medical issues, especially:

• Congestive heart failure or
• Coronary heart disease or
• Glaucoma or
• Heart disease (e.g., mitral stenosis) or
• Heart rhythm problems (e.g., arrhythmia) or
• Myasthenia gravis (serious muscle weakness) or
• Stomach or intestinal (bowel) blockage or
• Stomach ulcers or
• Urinary problems (e.g., bladder blockage due to an enlarged prostate)—Use with caution. May make these conditions worse.

• Allergy or intolerance to belladonna or salicylates—Use with caution. May be sensitive to this drug additionally.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Blurred vision
• dizziness
• rapid pulse

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Blue-colored urine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Phosphasal
• Urelle
• Uretron D/S
• Uribel
• Urimar-T
• UR N-C
• Ustell
• Uticap
• Utira-C
• Utrona-C

Available Dosage Forms:

• Tablet
• Capsule

Therapeutic Class: Urinary Antispasmodic

Pharmacologic Class: Hyoscyamine

Chemical Class: Salicylate, Non-Aspirin

Take this medicine for the full time of treatment, even if you begin to feel better. Also, keep your appointments with your doctor for check-ups so that your doctor will be better able to tell you when to stop taking this medicine.

Drink extra fluids after you take this medicine so you will pass more urine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For treatment of symptoms of urinary tract infection or diagnostic procedure: Adults—One tablet four times a day Children 7 years of age and older—Use and dose must be determined by your doctor. Children 6 years of age and younger—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.